Bone Resorption, Dental Implant Failed
Conditions
Keywords
Dental implants, Implant surfaces, Marginal bone loss
Brief summary
The purpose of this randomized controlled trial is to compare clinical data and implant stability of immediately loaded TSIII Osstem implants with Sandblasted and Acid-etched (SA) surface versus implants with SA surface modified with pH buffering agent for the rehabilitation of single implant-supported crown.
Detailed description
This study aimed to evaluate if there are some benefits using novel implant surface. This surface should improve the secondary implant stability, reducing the overall time needed for the osseointegration. main benefits in clinical practice should be reduced treatment time.
Interventions
PROCEDUREPlacement of dental implants (surgical procedure)
The two study implants have to be placed in the same surgical session according to similar procedures. Implants will be placed in the planned anatomic sites by using a flapless or a miniflap approach. Implants sites will be prepared based on the bone density, and according to the manufacturers's instruction by using the 122 Taper kit (Osstem Implant).
Sponsors
Osstem AIC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Implants have same macro design.
Intervention model description
Randomized controlled trial, split-mouth design
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Any partially edentulous subject requiring at least two single (preferable non-adjacent) implant-supported crowns, being at least 18 year old and able to sign an informed consent will be screened for eligibility. Bone volumes should allow the placement of two implants at least 8.5 mm (maximum 10 mm) long and 4.5 mm (minimum 3.5 mm) wide, with a minimal insertion torque of 30 Ncm. Implants can be placed in previous post-extractive socket or in augmented bone, if at least 4 to 6 months have passed from the extraction or from augmentation procedures.
Exclusion criteria
* Patients unable to commit to 5 years follow-up. * General contraindications to implant surgery. * Less then 4 mm of keratinised gingiva crestally (at the implant sites). * Immune-suppressed/compromised patients. * Patients irradiated in the head and/or neck. * Uncontrolled diabetes. * Pregnancy or lactation. * Untreated periodontal disease. * Poor oral hygiene and motivation (full mouth bleeding and full mouth plaque index higher than 25%). * Addiction to alcohol or drugs. * Psychiatric problems and/or unrealistic expectations. * Patients with an acute infection or suppuration in the site intended for implant placement. * Patients needing any form of tissue augmentation at implant placement. * Immediate post-extractive implants (implants can be placed after a 3-month healing period). * Patients treated or under treatment with intravenous amino-bisphosphonates. * Patients referred only for implant placement if the follow-up cannot be done at the treatment center. * Patients participating in other studies, if the present protocol could not be fully adhered to.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Implant failure | From implant placement up to 60 months after loading | Implant removal for any reason will be considered an implant failure. |
| Crown failure | From crown delivery up to 60 months | Crown replacement for any reason will be considered a crown failure. |
| Complications | From implant placement up to 60 months after loading | Any complications will be recorded. Examples of biological complications are: nerve injury, fistula, peri-implantitis. Examples of biomechanical complications are fracture of the abutments screw, loosening of the crown, fracture of the ceramic. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| plaque index (PI) | From implant placement up to 60 months after loading | Plaque index will be measured by a blinded operator, with a periodontal probe (PCP-UNC 15, Hu-Friedy Manufacturing, Chicago, IL, USA) at delivery of the definitive crowns, 1, 3, and 5 years follow-up in function. Three vestibular and three lingual values will be collected for each implant. |
| Peri-implant marginal bone level (MBL) changes | From implant placement up to 60 months after loading | It will be assessed on periapical radiographs taken with the paralleling technique. The distance between marginal bone level and implant/abutment junction, will be measured at both mesial and distal sides and averaged. Bone level changes at single implants will be averaged at group level. Non-digital radiographs will be scanned, digitized, and stored in a personal computer. Peri-implant marginal bone levels will be measured using the Scion Image (Scion Corporation, Frederick, MD, USA) software. The software will be calibrated for every single image using the known distance of the implant neck. Measurements of the mesial and distal bone crest level adjacent to each implant will be made to the nearest 0.01 mm. Reference points for the linear measurements will be: the coronal margin of the implant collar and the most coronal point of bone-to-implant contact. |
| Pink Esthetic Score | From crown delivery up to 60 months | The aesthetic evaluation will be performed according to the pink aesthetic score on the vestibular and occlusal pictures taken including at least one adjacent tooth per side.8 The values will be assessed at definitive prosthesis delivery, and then early up to the end of the follow-up. Seven variables (mesial papilla, distal papilla, soft-tissue level, soft-tissue contour, alveolar process deficiency, soft-tissue color and texture) will be assessed with a 2-1-0 score (2 being best and 0 being poorest) by the same blinded dentist. |
| Implant stability quotient | The ISQ values will be recorded at the time of implant placement (baseline) and then 1,2,3,4,5,6,7,8, and 12 weeks after implant placement. | The implant stability quotient will be recorded by the blind outcome assessor using resonance frequency analysis (Osstell Mentor; Osstell, Goteborg, Sweden).7 Buccopalatal and mesiodistal measurements will be taken and averaged, with the result being displayed by the device in ISQ units, ranging from 1 to 100. |
| Probing pocket depth (PPD) | From crown delivery up to 60 months | Probing pocket depth will be measured by a blinded operator, with a periodontal probe (PCP-UNC 15, Hu-Friedy Manufacturing, Chicago, IL, USA). Three vestibular and three lingual values will be collected and averaged for each implant. |
| Bleeding on probing (BOP) | From crown delivery up to 60 months | Bleeding on probing will be measured by a blinded operator, with a periodontal probe (PCP-UNC 15, Hu-Friedy Manufacturing, Chicago, IL, USA). Three vestibular and three lingual values will be collected and averaged for each implant. |
Countries
Albania, Bulgaria, Italy, Poland, Portugal, Romania, South Africa, Switzerland
Contacts
Primary ContactMarco Tallarico
Outcome results
None listed